Child DevelopmentNCT06198036
Effects of Hold-Relax and Muscle Energy Techniques for Hamstring Flexibility
A study testing Hold-Relax Technique and Muscle Energy Technique in people with Child Development, run by Riphah International University at 1 site in Pakistan.
Trial summary
The most important aspect of physical fitness is flexibility, which can be greatly impacted by bad posture. Long periods of sitting in school going children can cause the hamstring muscles to shorten because they bend the knee. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- Hold-Relax Technique and Muscle Energy Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 5 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 5-12 years children
- Gender (both male and female)
- Normal children
- Hamstring tightness (minimum degree <160 degrees
Who cannot join
- Regular athletes
- Past pathology
- Post fracture of limb
- Leg length discrepancy
- History of spinal cord injury
- Presence of physical deformities
- Subject not willing to participate
- Subject using lower limb prosthesis or orthotic device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Hold-Relax and Muscle Energy Techniques for Hamstring Flexibility In School Going Children
The most important aspect of physical fitness is flexibility, which can be greatly impacted by bad posture. Long periods of sitting in school going children can cause the hamstring muscles to shorten because they bend the knee. There are numerous methods for improving hamstring flexibility, but very few of them produce immediate results. The purpose of this study will be to compare between the immediate effects of hold-relax proprioceptive neuromuscular facilitation and muscle energy technique (MET) for hamstring flexibility in school going children. This will be the randomized clinical trial in which total time of six month will be utilized after the approval from BASR. Data will be collected from Unique Science School Al-Rehman Campus, Lahore. 106 participants will be taken with 05-12 years of age through purposive sampling technique. Participants will be divided into two equal groups. Participants in group A will be given hold-relax PNF and the group B will underwent METs (reciprocal inhibition). Hamstring ROM will be assessed through AKET. Measurements will be taken by goniometer. Wong-Baker faces pain scale (WBFPS) and Timed 'Up and Go' (TUG) test will be used to evaluate pain and functional mobility respectively. Data will be analyzed on SPSS version 25. Results after statistical analysis will show which technique is more effective and will have best outcomes.
Read the detailed description
The most important aspect of physical fitness is flexibility, which can be greatly impacted by bad posture that might occur from a sedentary lifestyle of a person and a reduction in the soft tissues' flexibility cause serious musculoskeletal injuries. Long periods of sitting in school going children can cause the hamstring muscles to shorten because they bend the knee. There are numerous methods for improving hamstring flexibility, but very few of them produce immediate results. The literature demonstrated that the two most successful stretching methods to compare were hold-relax and MET but there is paucity to determine their immediate effectiveness.
The purpose of this study will be to compare between the immediate effects of hold-relax proprioceptive neuromuscular facilitation and muscle energy technique (MET) for hamstring flexibility in school going children and to determine which strategy improves hamstring flexibility in school-aged children the fastest and with the best results. This will be the randomized clinical trial in which total time of six month will be utilized after the approval from BASR. Data will be collected from Unique Science School Al-Rehman Campus, Lahore. 106 participants will be taken with 05-12 years of age through purposive sampling technique. Participants will be divided into two equal groups. Participants in group A will be given hold-relax PNF and the group B will underwent METs (reciprocal inhibition). Hamstring ROM will be assessed through AKET. Measurements will be taken by goniometer. Wong-Baker faces pain scale (WBFPS) and Timed 'Up and Go' (TUG) test will be used to evaluate pain and functional mobility respectively. Data will be analyzed on SPSS version 25. Results after statistical analysis will show which technique is more effective and will have best outcomes
- Conditions
- Child Development
- Being tested
- Hold-Relax Technique, Muscle Energy Technique
- Keywords
- METs, Hamstring flexibility, School going children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hold-Relax TechniqueOther
Participants in this group will be treated with hold-relax PNF Technique
Muscle Energy TechniqueOther
Participants in this group will be treated with Muscle Energy Technique via Reciprocal Inhibition Mechanism
| Study group | Role | What they receive |
|---|---|---|
| Group A: Application of Hold-Relax PNF Technique | Active comparator | A hold-relax technique that entails stretching the muscle to its maximum length. Participant will be in supine position. The hamstring muscle will be stretched for 7 to 10 seconds while the individual reported only a slight stretch in the muscle. The participant then attempts to lower his leg towards the table while being resisted by the researcher, isometrically contracting his hamstring muscle for 3 seconds. The patient then instructed to relax for five seconds. The researcher then passively stretched the muscle until a slight sensation of stretch was experienced. The stretch will maintain for seven seconds. There were five repetitions of this sequence, each one 20 seconds apart from the previous one Receives: Other: Hold-Relax Technique |
| Group B: Application of Muscle Energy Technique | Active comparator | Group B will receive a Muscle Energy Technique (MET) applying the reciprocal inhibition principle. Participant will be in supine lying and the affected muscle held in a mid-range position. The Reciprocal Inhibition-MET group stretched for 10 to 60 seconds after performing an isometric contraction of the muscle opposite the one that needed to be stretched for 7 to 10 seconds (30%-50% of the time) followed by 5 second rest interval. With a pause of 20 seconds in between each repetition, this sequence was performed five times(52). The readings for Active knee Extension (AKE), TUG test and WBFPS before and after treatment session determined the improvement regarding the treatment outcomes. Receives: Other: Muscle Energy Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goniometer
The universal full circle goniometer is arguably the preferred instrument for measuring ROM for the majority of applications to the extremities. This version, which has a body, moving arm, and stationary arm, is the most prevalent. When comparing radiographic measurements with goniometric measurements in sedated and unsedated cats, joint measurements did not change significantly by measurement type. Cronbach alpha values for goniometric joint measurements were more than 0.99.
Measured: eight weeks
Active Knee Extension Test (AKET)
The Active Knee Extension Test measures the range of active knee extension when the hip is flexed as well as the length of the hamstring muscles. If the body positions are sufficiently stable, this test has a high degree of reliability. This test, a self-monitored variation of the active knee extension test, has also proven to be successful when performed by the person being tested. Among healthy individuals, the inter-rater and intra rater dependability has been proven.
Measured: eight weeks
Secondary outcomes (2)
Wong Baker Faces Pain Scale (WBFPS)
The Wong Baker Faces Pain Scale is a self-report tool designed to determine how much pain children are experiencing. Using scales of various facial expressions and matching a child's pain level to a similar face is one method of measuring pain in children. The Faces scale is an ordinal outcome measure that contains a minimal and predetermined number of categorical responses that are presented in a predetermined pattern. It is used to measure the rating of pain.
Measured: Eight weeks
Timed 'Up and Go' Test (TUG)
The Timed Up and Go test (TUG test), also used to measure functional mobility in children, is a useful tool. The TUG test calculates how long it takes to stand up, go forward 10 feet, turn around, move backward, and then sit down. The TUG test shows strong consistency and correlation with other evaluation instruments.
Measured: Eight Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Dec 2023
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be Randomized Clinical Trial to compare between the immediate effects of hold-relax Proprioceptive Neuromuscular Facilitation and Muscle Energy Technique (RI) for hamstring flexibility in school. Participants meeting the pre-determind inclusion and exclusion criteria will be divided into two groups going children
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sunnia Mudabber, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198036
- Sponsor's protocol ID
- REC/RCR&AHS/23/0733
- Status last verified
- Jun 2024
- First submitted
- 26 Dec 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Funk D, Swank AM, Adams KJ, Treolo D. Efficacy of moist heat pack application over static stretching on hamstring flexibility. J Strength Cond Res. 2001 Feb;15(1):123-6.
PubMed 11708695
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Hold-Relax and Muscle Energy Techniques for Hamstring Flexibility In School Going Children
- ClinicalTrials.gov ID
- NCT06198036
- Acronym / sponsor ID
- REC/RCR&AHS/23/0733
- Conditions
- Child Development
- Keywords
- METs, Hamstring flexibility, School going children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The most important aspect of physical fitness is flexibility, which can be greatly impacted by bad posture. Long periods of sitting in school going children can cause the hamstring muscles to shorten because they bend the knee. There are numerous methods for improving hamstring flexibility, but very few of them produce immediate results. The purpose of this study will be to compare between the immediate effects of hold-relax proprioceptive neuromuscular facilitation and muscle energy technique (MET) for hamstring flexibility in school going children. This will be the randomized clinical trial in which total time of six month will be utilized after the approval from BASR. Data will be collected from Unique Science School Al-Rehman Campus, Lahore. 106 participants will be taken with 05-12 years of age through purposive sampling technique. Participants will be divided into two equal groups. Participants in group A will be given hold-relax PNF and the group B will underwent METs (reciprocal inhibition). Hamstring ROM will be assessed through AKET. Measurements will be taken by goniometer. Wong-Baker faces pain scale (WBFPS) and Timed 'Up and Go' (TUG) test will be used to evaluate pain and functional mobility respectively. Data will be analyzed on SPSS version 25. Results after statistical analysis will show which technique is more effective and will have best outcomes.
Detailed description
The most important aspect of physical fitness is flexibility, which can be greatly impacted by bad posture that might occur from a sedentary lifestyle of a person and a reduction in the soft tissues' flexibility cause serious musculoskeletal injuries. Long periods of sitting in school going children can cause the hamstring muscles to shorten because they bend the knee. There are numerous methods for improving hamstring flexibility, but very few of them produce immediate results. The literature demonstrated that the two most successful stretching methods to compare were hold-relax and MET but there is paucity to determine their immediate effectiveness.
The purpose of this study will be to compare between the immediate effects of hold-relax proprioceptive neuromuscular facilitation and muscle energy technique (MET) for hamstring flexibility in school going children and to determine which strategy improves hamstring flexibility in school-aged children the fastest and with the best results. This will be the randomized clinical trial in which total time of six month will be utilized after the approval from BASR. Data will be collected from Unique Science School Al-Rehman Campus, Lahore. 106 participants will be taken with 05-12 years of age through purposive sampling technique. Participants will be divided into two equal groups. Participants in group A will be given hold-relax PNF and the group B will underwent METs (reciprocal inhibition). Hamstring ROM will be assessed through AKET. Measurements will be taken by goniometer. Wong-Baker faces pain scale (WBFPS) and Timed 'Up and Go' (TUG) test will be used to evaluate pain and functional mobility respectively. Data will be analyzed on SPSS version 25. Results after statistical analysis will show which technique is more effective and will have best outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study will be Randomized Clinical Trial to compare between the immediate effects of hold-relax Proprioceptive Neuromuscular Facilitation and Muscle Energy Technique (RI) for hamstring flexibility in school. Participants meeting the pre-determind inclusion and exclusion criteria will be divided into two groups going children
| Arm | Type | Receives |
|---|---|---|
| Group A: Application of Hold-Relax PNF Technique | Active comparator | Other: Hold-Relax TechniqueA hold-relax technique that entails stretching the muscle to its maximum length. Participant will be in supine position. The hamstring muscle will be stretched for 7 to 10 seconds while the individual reported only a slight stretch in the muscle. The participant then attempts to lower his leg towards the table while being resisted by the researcher, isometrically contracting his hamstring muscle for 3 seconds. The patient then instructed to relax for five seconds. The researcher then passively stretched the muscle until a slight sensation of stretch was experienced. The stretch will maintain for seven seconds. There were five repetitions of this sequence, each one 20 seconds apart from the previous one |
| Group B: Application of Muscle Energy Technique | Active comparator | Other: Muscle Energy TechniqueGroup B will receive a Muscle Energy Technique (MET) applying the reciprocal inhibition principle. Participant will be in supine lying and the affected muscle held in a mid-range position. The Reciprocal Inhibition-MET group stretched for 10 to 60 seconds after performing an isometric contraction of the muscle opposite the one that needed to be stretched for 7 to 10 seconds (30%-50% of the time) followed by 5 second rest interval. With a pause of 20 seconds in between each repetition, this sequence was performed five times(52). The readings for Active knee Extension (AKE), TUG test and WBFPS before and after treatment session determined the improvement regarding the treatment outcomes. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 5-12 years children
- Gender (both male and female)
- Normal children
- Hamstring tightness (minimum degree <160 degrees
Key exclusion criteria (8 listed)
- Regular athletes
- Past pathology
- Post fracture of limb
- Leg length discrepancy
- History of spinal cord injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hold-Relax TechniqueParticipants in this group will be treated with hold-relax PNF Technique | Other | Group A: Application of Hold-Relax PNF Technique |
| Muscle Energy TechniqueParticipants in this group will be treated with Muscle Energy Technique via Reciprocal Inhibition Mechanism | Other | Group B: Application of Muscle Energy Technique |
Primary outcome
Goniometer
Time frame: eight weeks
The universal full circle goniometer is arguably the preferred instrument for measuring ROM for the majority of applications to the extremities. This version, which has a body, moving arm, and stationary arm, is the most prevalent. When comparing radiographic measurements with goniometric measurements in sedated and unsedated cats, joint measurements did not change significantly by measurement type. Cronbach alpha values for goniometric joint measurements were more than 0.99.
Active Knee Extension Test (AKET)
Time frame: eight weeks
The Active Knee Extension Test measures the range of active knee extension when the hip is flexed as well as the length of the hamstring muscles. If the body positions are sufficiently stable, this test has a high degree of reliability. This test, a self-monitored variation of the active knee extension test, has also proven to be successful when performed by the person being tested. Among healthy individuals, the inter-rater and intra rater dependability has been proven.
2 secondary outcomes
Wong Baker Faces Pain Scale (WBFPS)
Time frame: Eight weeks
Timed 'Up and Go' Test (TUG)
Time frame: Eight Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Background: PubMed 11708695Funk D, Swank AM, Adams KJ, Treolo D. Efficacy of moist heat pack application over static stretching on hamstring flexibility. J Strength Cond Res. 2001 Feb;15(1):123-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunnia Mudabber, MS* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hold-Relax Technique and Muscle Energy Technique in people with Child Development, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goniometer (time frame: eight weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06198036, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.